NCT05903742 Standardising Care for Hepatitis Delta in the Netherlands
| NCT ID | NCT05903742 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Erasmus Medical Center |
| Condition | Hepatitis D |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-01-22 |
| Primary Completion | 2030-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2024-01-22 with a primary completion date of 2030-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Rationale: Hepatitis delta virus (HDV) is a defective RNA virus that requires presence of hepatitis B virus (HBV) to complete virion assembly and secretion. HBV-HDV coinfection ("hepatitis delta") has been associated with severe liver injury that may result in rapid progression to cirrhosis and hepatic decompensation, as well as a higher risk of liver cancer when compared to patients with HBV mono-infection. Given the low incidence of hepatitis D, experience in caring for individuals with hepatitis delta is limited and management practices vary. Objective: Generate prospective follow-up data to increase our understanding of this rare disease. Study design: Prospective observational cohort study spanning 5 years, during which we will collect standard clinical data as well as blood samples and quality of life questionnaires. Study population: hepatitis delta patients aged ≥18 years Intervention (if applicable): not applicable Main study parameters/endpoints: Incidence of liver related events (liver cancer, (decompensation of) cirrhosis, liver transplantation) during follow-up and changes in markers of viral replication, inflammatory activity and liver stiffness over time. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risks associated with participation can be considered negligible and the burden can be considered minimal. The only additional action that the participants must perform are the filling out of two annual quality of life questionnaires, which are considered non-invasive, and collection of 10 ml blood during regular blood sample collections
Eligibility Criteria
Inclusion Criteria: * Active hepatitis delta based on a positive anti-HDV and a positive HDV-RNA test * Patients must be ≥18 years * Written informed consent Exclusion Criteria: * None
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05903742 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hepatitis D. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05903742 currently recruiting?
Yes, NCT05903742 is actively recruiting participants. Contact the research team at l.patmore@erasmusmc.nl for enrollment information.
Where is the NCT05903742 trial being conducted?
This trial is being conducted at Rotterdam, Netherlands.
Who is sponsoring the NCT05903742 clinical trial?
NCT05903742 is sponsored by Erasmus Medical Center. The trial plans to enroll 80 participants.